§ Mr. Austin MitchellTo ask the Minister of Agriculture, Fisheries and Food how many EC countries implemented EC directive 81/851 on the harmonising of veterinary products by(a) automatically renewing the licences of current medicines and (b) by a fresh process of relicensing; what considerations led him to opt for the latter approach for the United Kingdom; what are the costs of relicensing a medicine through the Veterinary Medicines Directorate; and how many existing products have not been submitted for relicensing.
§ Mr. SoamesAll member states have been required to apply the full provisions of Directive 81/851 to long standing pharmaceutical veterinary medicinal products, and this approach has been adopted within the United Kingdom. While details of implementation in other countries are a matter for those countries and the EC Commission, the directive does not allow for automatic renewal of licences in respect of old products and we are not aware of any member state which has done this.
No fee is charged for the review of an old product in the United Kingdom. The costs to the company are variable, and will depend on what data are necessary to demonstrate that a product meets current standards of safety, quality and efficacy. As at 25 June 1993, 1,727 such products (63 per cent. of those called for review) have had their licences withdrawn or allowed to expire in the United Kingdom. This is comparable to my understanding of the position in France (68 per cent.) and Spain (56 per cent.).